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EchoSoft

by Echometrix, LLC

510(k) K111142

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK111142 Date21 Sep 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Echosoft(Tm)
510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

EchoSoft is a Class II X‑ray system component marketed by Echometrix, LLC. It is identified in the FDA filing as substantially equivalent to existing radiology devices and is listed under product code LLZ.

The device received traditional 510(k) clearance (K111142) on 2012‑09‑21 and is regulated as a Class II medical device in the United States. It is supplied by Echometrix, LLC in Waukesha, Wisconsin, and is identified without any trademark symbols or marketing qualifiers.

Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ECHOSOFT(TM) device used for?

    EchoSoft is a Class II X-ray system component marketed by Echometrix, LLC, and is identified in the FDA filing as substantially equivalent to existing radiology devices, indicating it performs similar functions to legally marketed predicate devices in radiology applications.

  • How is the ECHOSOFT(TM) device supplied and by whom?

    EchoSoft is supplied by Echometrix, LLC from their facility located at 2210 Woodhill Way, Waukesha, Wisconsin, 53189, United States, and is distributed without trademark symbols or marketing qualifiers as part of its regulatory labeling.

  • What regulatory pathway was used for the ECHOSOFT(TM) device clearance?

    EchoSoft received traditional 510(k) clearance under number K111142 on September 21, 2012, based on a determination of substantial equivalence to existing Class II radiology devices under product code LLZ.